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The CLUNGENE Multi-Drug Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

The single or multi-test cups can consist of any combination of the above listed drug analytes, but only one cut off concentration under same drug condition will be included per device.

This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The CLUNGENE Multi-Drug Home Test Easy Cup is a lateral flow immunoassay for the qualitative detection of Morphine, Methamphetamine, Cocaine, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Propoxyphene, Amphetamine, Phencyclidine, EDDP (Methadone metabolite), Oxycodone, Oxazepam, Nortriptyline, Secobarbital, Methadone, 6-Monoacetylmorphine and Fentanyl in human urine at the following cut off concentrations:

The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC-MS/MS is the preferred confirmatory method.

It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.

CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.
The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

This document provides details on the performance characteristics of the CLUNGENE Multi-Drug Test Easy Cup and CLUNGENE Multi-Drug Home Test Easy Cup. Since this is an in vitro diagnostic device (specifically, a drug screening test), the acceptance criteria and study design are typically focused on analytical performance (accuracy, precision, analytical specificity) rather than a multi-reader multi-case (MRMC) comparative effectiveness study, which is more common for imaging AI. Similarly, "human readers improving with AI vs without AI" is not applicable here as the device is the test, not an aid to human interpretation of another modality.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for qualitative drug screening tests like this is accurate detection around a specific cutoff concentration. The reported performance demonstrates the device's ability to correctly classify samples as positive or negative relative to these cutoffs.

Table of Acceptance Criteria and Reported Device Performance (Analytical Precision/Reproducibility)

The "Acceptance Criteria" column represents the desired performance for a qualitative assay around its cutoff. For positive results, this means detecting drug concentrations above the cutoff, and for negative results, it means not detecting concentrations below the cutoff. The provided precision data shows the number of positive (+) and negative (-) results out of 50 tests for various concentrations relative to the cutoff. An ideal performance would show 100% positive for concentrations above cutoff and 100% negative for concentrations below, with roughly 50/50 split at the cutoff itself (due to inherent variability).

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The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:

Configuration of the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs above when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:

Configuration of the AssureTech Multi-drug Urine Test Cup can consist of any combination of the above listed drug analytes. It is for in vitro diagnostic use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided FDA 510(k) Clearance Letter details the performance of the AssureTech Quick Cup Tests and AssureTech Multi-drug Urine Test Cup for qualitative and simultaneous detection of various drugs in human urine.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria:

1. Acceptance Criteria and Reported Device Performance

For in vitro diagnostic devices like these, acceptance criteria are typically related to the accuracy of the qualitative detection (positive vs. negative) compared to a gold standard, particularly around the established cutoff concentrations. The performance is assessed through analytical studies (precision, specificity, interference) and comparison studies with a confirmatory method.

Here's a table summarizing the implicit acceptance criteria based on the precision and lay-user studies, and the reported device performance. The acceptance criterion is inferred as the ideal performance for these types of tests, where results near or above the cutoff should be positive, and results significantly below should be negative. The performance data below is extracted from the "Precision" and "Lay-user study" sections.

Table of Acceptance Criteria and Reported Device Performance

Note: The precision study for AMP300, MET300, and TML100 used 3 lots, with "50-/0+" meaning 50 negative results and 0 positive results, and "50+/0-" meaning 50 positive results and 0 negative results. For the 'Cutoff' concentration, it shows a mix of positive and negative results, which is expected due to the nature of qualitative assays around the threshold.

2. Sample Sizes and Data Provenance

• Precision Study:

  • For AMP300, MET300, and TML100: Each drug had 8 concentrations (spanning -100% to +100% of cutoff, plus the cutoff). For each concentration, tests were performed two runs per day for 25 days, for 3 different lots.
    • This means 50 observations per concentration per lot (2 runs/day * 25 days/run).
    • Total observations per drug for all 3 lots: 8 concentrations * 50 observations/concentration * 3 lots = 1200 observations per drug.
  • Data for other drugs refer to previous 510(k) clearances (K243996, K201630, K181768, K180349, K170049, K161044, K153465, K152025, K151211).
  • Data Provenance: Retrospective, as samples were "prepared by spiking drug in negative samples" and confirmed by LC/MS. No specific country of origin is mentioned, but typically for FDA submissions, studies are conducted under GLP (Good Laboratory Practice) guidelines, often in the US or by international labs adhering to comparable standards.

• Comparison Studies (Clinical Samples):

  • For AMP300, MET300, and TML100: The tables show data broken down by "Negative" (presumably drug-free), "Low Negative" ( +50%). The sum of the positive and negative results across these categories for each operator represents the number of clinical samples tested for that drug.
    • AMP300: 5 (Negative) + 15 (LN) + 19 (NCN) + 24 (NCP) + 16 (HP) = 79 samples per operator. (Operator 1)
    • MET300: 4 (Negative) + 13 (LN) + 23 (NCN) + 20 (NCP) + 20 (HP) = 80 samples per operator. (Operator 1)
    • TML100: 2 (Negative) + 18 (LN) + 18 (NCN) + 19 (NCP) + 20 (HP) = 77 samples per operator. (Operator 1)
    • Total (approximate, as numbers vary slightly between operators): ~79+80+77 = ~236 clinical samples for AMP300, MET300, TML100 combined.
  • Data for other drugs refer to previous 510(k) clearances.
  • Data Provenance: Retrospective, using "unaltered clinical samples." No specific country of origin is mentioned.

• Lay-User Study:

  • Sample Size: 280 lay persons tested the device.
    • Configuration 1: 66 male + 74 female = 140 lay persons.
    • Configuration 2: 87 male + 53 female = 140 lay persons.
  • Data Provenance: Retrospective, samples were "prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens." Confirmed by LC/MS. Conducted "at three intended user sites." No specific country of origin is mentioned.

3. Number of Experts and Qualifications for Ground Truth (Clinical Samples)

• Ground Truth Establishment for Clinical Samples: LC/MS (Liquid Chromatography/Mass Spectrometry) is stated as the preferred confirmatory method and was used to confirm the concentrations of the samples. This is an objective chemical method, considered the gold standard for drug detection and quantification in urine.
• Experts: The comparison studies were performed "in-house with three laboratory assistants." While these individuals are performing the rapid tests, the ultimate ground truth is established by the LC/MS results. The "laboratory assistants" are not explicitly designated as "experts" in establishing ground truth, but rather as trained users of the device whose results are compared to the LC/MS gold standard.

4. Adjudication Method for the Test Set (Clinical Samples)

• The document states that "Operators ran unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results."
• There were three operators. The "Discordant Results" tables show discrepancies between the rapid test results and the LC/MS results, sometimes across multiple operators for the same sample.
• No explicit adjudication method (e.g., 2+1, 3+1) for the rapid test results themselves is described. The comparison seems to be a direct comparison of each operator's rapid test result against the LC/MS ground truth, and then discrepancies are noted. The LC/MS data serves as the final, objective ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• This document describes performance characteristics of an in-vitro diagnostic device (a qualitative urine drug test cup).
• No MRMC comparative effectiveness study was performed in the context of comparing human readers (e.g., radiologists interpreting images) with and without AI assistance. This type of study design is specific to AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) devices in imaging, which is not applicable to a lateral flow immunoassay like the AssureTech Quick Cup Tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Given this is a physical immunoassay test cup, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not directly apply in the same way it would for a software-based AI device.
• The "Comparison Studies" with laboratory assistants and the "Lay-user study" assess the device's performance when interpreted by human users. The device itself, by producing a visual result (line/no line), is the "algorithm." Its performance is inherently tied to human interpretation of that visual output. The precision and specificity studies represent the analytical performance of the device itself.

7. Type of Ground Truth Used

• Analytical Performance Studies (Precision, Specificity, pH/SG Effect): The ground truth was established by spiking known concentrations of drugs into negative urine samples, with concentrations confirmed by LC/MS.
• Comparison Studies (Clinical Samples): The ground truth was established by LC/MS results on unaltered clinical urine samples. LC/MS is a highly accurate chemical analytical method.
• Lay-User Study: Ground truth was established by spiking known concentrations of drugs into drug-free pooled urine specimens, confirmed by LC/MS.

8. Sample Size for the Training Set

• This document describes a 510(k) submission for a traditional in-vitro diagnostic device (immunoassay). It does not mention any artificial intelligence (AI) or machine learning (ML) components that would typically require a "training set" in the computational sense.
• The terms "training set" and "test set" are common in AI/ML validation. For a traditional medical device, the studies described (precision, interference, specificity, comparison, lay-user) serve as the "validation set" against pre-defined performance criteria.
• Therefore, N/A for "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

• N/A (as above, no "training set" in the AI/ML context).
• However, if we consider how the device itself was developed, the ground truth for optimizing its performance (e.g., antibody binding, membrane characteristics) would have relied on highly controlled experiments with known concentrations of analytes, likely confirmed by advanced analytical chemistry methods like LC/MS. This process is part of the extensive R&D and quality control that precedes a 510(k) submission.

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AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.

The provided document describes the analytical and user performance of the "AllTest Multi-Drug Rapid Urine Test Cup" and "AllTest Multi-Drug Urine Test Cup" for detecting various drugs in human urine.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for sensitivity, specificity, or agreement. However, the performance studies demonstrate that the device is designed to correctly identify drug presence/absence relative to a defined cutoff concentration. For qualitative drug tests, a common expectation is high agreement rates for samples significantly above or below the cutoff, with some variability allowed for samples near the cutoff.

The reported device performance can be summarized from the precision and lay person studies. The precision studies show ideal performance at concentrations far from the cutoff (100% agreement), and expected variability (around 50% positive/negative calls) at the cutoff concentration. The lay person study similarly shows very high agreement (typically 90-100%) for samples adequately far from the cutoff concentration.

Since no explicit quantitative acceptance criteria are given in the provided text, the reported performance is presented in relation to the ideal behavior of a qualitative assay around its cutoff.

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AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencycline, Nortriptyline, Marijuana, Tramadol, Propoxyphene, Fentanyl and 6monoacetylmorphine in human urine at the cutoff concentrations of:

est Multi-Drug Rapid Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Test Cup

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the performance characteristics demonstrated in the studies, particularly the agreement/precision at and around the cutoff concentrations, and the specificity. Since this is an in vitro diagnostic (IVD) device, the "performance" here refers to its accuracy in detecting the target analytes and its overall reliability in a diagnostic context. This is fundamentally about how well the device matches a known, established ground truth.

• Agreement at -100%, -75%, -50% Cutoff: Generally 100% negative agreement.
• Agreement at +50%, +75% Cutoff: Generally 100% positive agreement.
• Agreement at -25% and +25% Cutoff: Ranged from 85.0% to 95.0% negative/positive agreement, respectively, demonstrating expected variability around the cutoff.
  All participants found the instructions easy to understand and follow (Flesch-Kincaid Grade Level 7). |

2. Sample Size Used for the Test Set and Data Provenance

• Precision/Reproducibility Study:

  • Sample Size: For each drug and each concentration (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100% of cutoff), tests were performed in 2 runs per day for 25 days, using 3 lots of test cups. This means for each concentration and drug, there were 50 tests per lot (2 runs/day * 25 days) and 150 tests across 3 lots.
  • Data Provenance: Urine samples spiked with target drugs into drug-free urine. The drug concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study, not from actual patients.

• Analytical Specificity/Interference Study:

  • Sample Size: Not explicitly stated as a total number, but drugs and interfering compounds were spiked into drug-free urine samples and tested using 3 lots of devices for each interference condition.
  • Data Provenance: Laboratory prepared urine samples (drug-free urine spiked with various compounds).

• Method Comparison Study:

  • Sample Size: 80 unaltered urine clinical samples (40 negative and 40 positive) for each drug.
  • Data Provenance: Unaltered clinical urine samples. The country of origin is not specified but it is an in-house study.

• Lay Person Study:

  • Sample Size: 280 lay persons.
  • Data Provenance: Urine samples prepared by spiking drug(s) into drug-free pooled urine specimens. The concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study designed to evaluate user comprehension and ease of use, not true clinical performance with patient samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Precision/Reproducibility, Analytical Specificity/Interference, Lay Person Study: Ground truth was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and standardized analytical method for drug concentration determination. No human experts were explicitly stated to establish this ground truth, as it's an objective chemical analysis.

• Method Comparison Study: Ground truth was established by LC-MS/MS. Similar to the above, this is an objective analytical method.

4. Adjudication Method for the Test Set

• For the Method Comparison Study, the device results were compared directly to the LC-MS/MS results. There is no mention of an adjudication process (e.g., 2+1, 3+1 expert review) for the ground truth itself, as LC-MS/MS is considered the definitive truth.
• For the Lay Person Study, the "ground truth" for the expected positive/negative call was based on the known spiked concentrations confirmed by LC-MS/MS. The participants' interpretations of the device results were then compared to this established truth. There was no adjudication of the lay person's reading, but rather an assessment of their accuracy against the known sample content.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done.
• This device is a qualitative lateral flow immunochromatographic assay ("rapid test cup") for in vitro diagnostic use, intended for direct reading by a user (either professionals or lay persons). It does not involve AI or human readers interpreting complex images or data assisted by AI.
• The closest analogy is the "Lay Person Study," which assesses how well lay users can interpret the results without assistance on complex outputs, but there is no AI component.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, in spirit, the analytical performance studies (precision, specificity, stability) and the LC-MS/MS ground truth in the method comparison study represent "standalone" performance. The device itself (the immunochromatographic strip) is the "algorithm," and its chemical reactions are assessed according to established scientific principles, independent of human interpretation prior to result line formation.
• However, the final reading of the lines on the rapid test cup is still a human-in-the-loop step, even for laboratory personnel in the precision and method comparison studies, and especially for lay users in their study. The intent of these "rapid test" types of devices is precisely for direct human interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The primary ground truth used across all analytical and method comparison studies was LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and quantitative laboratory method used for definitive drug detection and concentration measurement.

8. The Sample Size for the Training Set

• This submission describes a premarket notification (510(k)) for an in vitro diagnostic device. Unlike AI/ML devices, these types of products typically do not involve "training sets" in the machine learning sense.
• The manufacturing process, antibody selection, and assay design for these immunochromatographic tests are developed and refined through internal R&D, often using a range of samples and iterations. The document does not describe a formal 'training set' analogous to those used for AI algorithms. The data presented are for validation and verification of the finished device.

9. How the Ground Truth for the Training Set was Established

• As noted above, a "training set" in the AI/ML context is not applicable here. The development of the reagents and test design would have relied on standard laboratory practices for developing highly specific and sensitive immunoassays, with positive and negative controls and calibration against known concentrations, usually verified by gold-standard analytical methods like LC-MS/MS.

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The AssureTech Panel Dip Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Methamphetamine, Fentanyl, Norfentany], Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations listed. The single or multi-test panels can consist of up to seventeen (17) of the above listed analytes in any combination. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

The AssureTech Multi-drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test panel can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Fentanyl, Norfentanyl, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene and adulterants in human urine at the cutoff concentrations listed. The single or multi-test cups can consist of up to seventeen (17) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Fentanyl, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP. Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single use in vitro diagnostic devices, which come in the formats of Panel Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the FDA 510(k) premarket notification for AssureTech Panel Dip Tests and Quick Cup Tests, which are in vitro diagnostic devices for qualitative and simultaneous detection of various drugs of abuse in human urine. The document focuses on demonstrating substantial equivalence to a predicate device (K181768).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily related to its analytical performance, specifically its ability to accurately detect the presence or absence of target drugs at specified cutoff concentrations. The device is a qualitative test, meaning it provides a "positive" or "negative" result, rather than a quantitative measurement.

The study demonstrates performance through:

• Precision: Consistency of results across multiple runs and lots, especially near the cutoff concentrations.
• Specificity: Ability to react only with the target drug/metabolite and not with other substances or structurally similar compounds.
• Interference: Lack of false positives/negatives due to common interfering substances in urine, or variations in urine specific gravity and pH.
• Method Comparison: Agreement of device results with a known, more precise reference method (LC/MS).
• Lay-user study: Evaluation of the device's performance when used by non-professionals, assessing ease of use and accuracy of interpretation.

Here is a table summarizing the reported device performance for Fentanyl (FYL), Norfentanyl (NFYL), and as an example for another drug, Amphetamine (AMP) from the "Lay-user study" data. The document does not explicitly state numerical "acceptance criteria" for each performance metric, but rather presents the results of the studies conducted to show sufficient performance for regulatory clearance. The implicit acceptance criterion for a qualitative test like this is generally very high accuracy, especially around the cutoff, and a low rate of false positives/negatives.

Table of Performance for Key Drugs (Fentanyl, Norfentanyl, Amphetamine)

Precision Study (Fentanyl - Panel Dip/Quick Cup, Norfentanyl - Panel Dip/Quick Cup):
The precision data is presented for three lots and various concentrations relative to the cutoff. The data shows very high consistency. For instance, for Fentanyl:

• At -100%, -75%, -50% cut off (negative range), all 50 tests across 3 lots consistently yielded negative results (50-/0+).
• At +25%, +50%, +75%, +100% cut off (positive range), all 50 tests consistently yielded positive results (50+/0-).
• At the cutoff concentration, the device shows variability, as expected for tests near the decision threshold. For Fentanyl Panel Dip, results were 28+/22-, 29+/23-, 28+/22- for Lot 1, 2, 3 respectively (meaning some tests were positive and some negative at the cutoff). This variability is inherent for qualitative tests around the cutoff and implies that some samples at the cutoff may read positive and others negative, which is acceptable performance for a qualitative test. Similar patterns are observed for Quick Cup Fentanyl, Panel Dip Norfentanyl, and Quick Cup Norfentanyl.

Method Comparison Study (Fentanyl - Panel Dip/Quick Cup, Norfentanyl - Panel Dip/Quick Cup):
This study compared the device results against LC/MS, the preferred confirmatory method. The results are presented in tables showing agreement across different concentration ranges (Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive).

Example for FYL (Fentanyl) - Panel Dip, Operator 1:

• Negative (LC/MS 0): Device: 0 Positive, 1 Negative (1 discordant result here, sample 1484, LC/MS 0.78 ng/mL, Device: +)
• Low Negative (LC/MS +50%): Device: 20 Positive, 0 Negative

Lay-User Study (Selected data for AMP, FYL, NFYL):
This study evaluates the percentage of correct results when used by lay persons at various concentrations relative to the cutoff.

Example for AMP (Amphetamine):

• Negative (100% below cutoff): 100% correct (0 positive, 20 negative)
• Low Negative (-75% to -25% Cutoff): 100% correct negative for -75% and -50%, but 0 positive/20 negative for -25% cutoff.
• Positive (+25% to +75% Cutoff): Generally high correctness (95%-100%). For +25% cutoff, 95% correctness (19 positive, 1 negative).

Detailed Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Precision Study: For Fentanyl and Norfentanyl, the reported data is for 3 lots, with 2 runs per day for 25 days, for 9 concentrations (e.g., -100% cutoff, -75% cutoff, etc.). This implies 50 tests per concentration per lot (2 runs * 25 days), leading to 450 tests per drug type per lot (9 concentrations * 50 tests), and 1350 tests per drug type across all 3 lots. The data provenance implies these samples were prepared by spiking known concentrations of drug into negative samples, indicating a controlled laboratory environment. Data for other analytes was "reported in K181768" (the predicate device documentation), so the exact sample sizes are not explicitly stated in this document but are assumed to be similar.
   • Method Comparison Study: For Fentanyl and Norfentanyl, 80 unaltered clinical samples (40 negative and 40 positive based on LC/MS results) were used per drug. Each sample was tested by three laboratory assistants for each device type (Panel Dip and Quick Cup). This means 80 samples * 3 operators = 240 tests per drug for each device type. The data provenance is "in-house" and "unaltered clinical samples." The document does not specify the country of origin, but given the FDA submission, it's likely US-based or compliant with US standards. The study appears to be retrospective, using already collected clinical samples for comparison.
   • Lay-user Study: 280 lay persons were used for each device format (Panel Dip and Quick Cup, though the results summarized apply to the overall device type). Urine samples were prepared at 7 different concentrations (negative, +/-25%, +/-50%, +/-75%, +/-100% of cutoff). Each participant received one blind-labeled sample and one device. Assuming each person tested one sample, this implies 280 samples were tested for each specific drug evaluated by lay-users on each format. The data provenance: "samples were prepared by spiking drugs into drug-free pooled urine specimens" and confirmed by LC/MS. This is a controlled experimental set-up rather than real-world patient samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Precision Study: Ground truth was established by spiking known concentrations of drugs into negative samples and confirmed by LC/MS. No human experts were involved in establishing the ground truth directly for this part.
   • Method Comparison Study: The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is explicitly stated as the "preferred confirmatory method" and is considered a gold standard for drug detection and quantification in urine. No human expert readers established the ground truth; it was a laboratory instrument measurement. The study used three laboratory assistants to read the device results, but they were comparing their readings against the LC/MS truth, not establishing the truth themselves. Their qualifications are not specified beyond "laboratory assistants."
   • Lay-user Study: The ground truth was established by spiking known concentrations of drugs confirmed by LC/MS. No human experts established the ground truth of the samples. The study assessed the lay-users' ability to interpret the device results against this known truth.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Precision Study: No adjudication method mentioned as samples were prepared with known concentrations.
   • Method Comparison Study: No adjudication method was explicitly mentioned for the device results. Each of the three operators performed their own reads, and their individual results were compared to the LC/MS. Discordant results are noted for each operator.
   • Lay-user Study: No adjudication method was mentioned. Each lay user tested one sample against a pre-defined truth.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in this report. This device is a rapid diagnostic test (lateral flow immunoassay), not an AI-assisted diagnostic tool for interpretation of medical images or other complex data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is a lateral flow immunoassay, which is a physical diagnostic device producing a visual result (colored lines). It does not involve an "algorithm" in the sense of a software-based AI or computational algorithm. The device itself is the "standalone" diagnostic. Its performance characteristics (precision, specificity, interference) are essentially its "algorithm only" performance. The method comparison study is akin to assessing the device's standalone performance against a gold standard. The lay-user study assesses human interpretation of the device's standalone output.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The primary ground truth for the analytical and method comparison studies was Liquid Chromatography-Mass Spectrometry (LC/MS), which is a highly accurate chemical method for detecting and quantifying substances.
   • For the precision and lay-user studies, the ground truth was based on spiked urine samples with known drug concentrations, which were then confirmed by LC/MS.

7. The sample size for the training set:

   • This document describes a 510(k) premarket notification for an in vitro diagnostic device (lateral flow immunoassay). Unlike AI/ML-driven devices that require extensive training data, such chemical-based devices are developed and optimized through chemical engineering and biological principles, not by "training" on datasets in the AI sense. Therefore, the concept of a "training set" with a statistical sample size as understood in machine learning is not applicable to this type of device. The development process involves chemical formulation and validation, not data training.

8. How the ground truth for the training set was established:

   • Since the concept of a "training set" as it pertains to AI/ML devices is not applicable, the establishment of ground truth for a training set is also not relevant in this context. The "ground truth" for the performance evaluation of the device relied on LC/MS results and carefully prepared spiked samples with known drug concentrations.

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Pocguide Multi-Drug Test Panel OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxy-methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

The single or multi-test panels can consist of up to the above listed analytes in any combination. The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

For over-the-counter use. For in vitro diagnostic use only

Pocguide™ Multi-Drug Test Panel and Pocguide™ Multi-Drug Test Panel OTC are immunochromatographic assays that use a lateral flow system for the qualitative detection of single drugs in human urine at or above the cut-off levels as indicated. The products are single use in vitro diagnostic devices.

This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.

The provided document describes the Pocguide Multi-Drug Test Panel and Pocguide Multi-Drug Test Panel OTC, which are in vitro diagnostic devices for qualitative and simultaneous detection of various drugs in human urine.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of qualitative diagnostic device are typically related to its analytical performance, specifically precision (reproducibility) around the cutoff concentration, and its ability to correctly identify positive and negative samples when compared to a confirmed method (method comparison).

Acceptance Criteria (Implied based on study design and regulatory context for qualitative drug tests):

• Precision/Reproducibility: A high percentage of agreement (e.g., typically >80%) for samples near the cutoff (e.g., +/- 25% cutoff, cutoff itself) over multiple lots and runs, and 100% agreement for samples far from the cutoff (e.g., +/- 100% cutoff).
• Method Comparison: High overall agreement (sensitivity and specificity) with a gold standard confirmatory method (LC/MS or GC/MS) for clinical samples, especially for true positive and true negative samples. Acceptable performance for samples near the cutoff where some discordance is expected due to the nature of qualitative assays.
• Analytical Specificity (Cross-Reactivity): No significant cross-reactivity with common substances or structurally similar compounds to avoid false positives.
• Interference: No interference from common physiological substances found in urine.
• Lay-User Study (for OTC devices): High agreement with trained professionals and ease of use for the intended lay user.

Reported Device Performance (from "Precision/Reproducibility" and "Method Comparison" sections):

• AMP 500: 82.0% Positive, 18.0% Negative
• BUP 10: 84.0% Positive, 16.0% Negative
• BAR 300: 82.7% Positive, 17.3% Negative
• And similar ranges for other drugs listed in Table 2. Each drug showed similar performance around the cutoff. |
  | Method Comparison | AMP 1000 ng/mL, AMP 500 ng/mL, BAR 300 ng/mL, etc. | Excellent agreement for Drug-Free, Low Negative, and High Positive Samples: Typically 100% correct classification by the device for these categories (e.g., "Viewer A Positive" for High Positive by LC/MS and "Viewer A Negative" for Drug-Free by LC/MS are 100% for almost all drugs).
  Expected Discordance Near Cutoff: As anticipated for qualitative tests, some samples near the cutoff (especially -25% and +25%) show mixed results (discordance) between the device and LC/MS, as detailed in Table 5 and Table 6 (Discordant results). These are typically within acceptable ranges for qualitative tests, acknowledging the inherent variation around a precise cutoff. |
  | Analytical Specificity | AMP, BUP, BAR, etc. | Tested numerous substances. Most showed no cross-reactivity or very low percentages at very high concentrations, indicating good specificity. Specific cross-reactivity percentages are provided in Table 3. |
  | Interference | N/A - broadly tested | No interference observed for a wide range of common substances and physiological conditions (urine specific gravity 1.000-1.035, pH 4-9) as listed in Tables 4. |
  | Lay-User Study | All Configuration 1 & 2 Drugs | Agreement (%):
• -100%, -75%, -50% Cutoff: 100% negative calls.
• +25%, +50%, +75% Cutoff: Mostly 100% positive calls, some 95% for +25% cutoff.
• -25% Cutoff: 95% negative calls for most drugs.
• Raw numbers show 19/20 or 20/20 correct calls for most categories.
  Ease of Use: All participants indicated instructions were easy to understand and follow (Flesch-Kincaid Grade Level 7). |

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Precision/Reproducibility: For each drug and each cutoff, 50 samples were tested at each concentration level (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%). This was done across 3 lots, so $50 \text{ samples/level} \times 9 \text{ levels} \times 3 \text{ lots} = 1350$ tests per drug. (For AMP alone, this would be $1350 \times 2 \text{ cutoffs} = 2700$ tests).
  • Method Comparison: 100 unaltered clinical samples were used for each target drug (40 negative, 40 positive, and an additional 20 samples around the cutoff as seen in the breakdown of results). So, for 13 drug analytes, this would be $13 \times 100 = 1300$ clinical samples.
  • Cross-Reactivity / Interference: Specific numbers for each substance are not given, but samples were spiked at various concentrations and tested using three lots of each device.
  • Lay-User Study: For Configuration 1, 140 participants (58 male, 82 female). For Configuration 2, 140 participants (56 male, 84 female). Each participant tested 1 blind-labeled sample. For each drug within each configuration, 20 samples were prepared per concentration level (-100%, -75%, -50%, -25%, +25%, +50%, +75%).
• Data Provenance: The document does not explicitly state the country of origin for the data. The consulting firm is in Shanghai, China, and the applicant's address is Irvine, CA, USA. Given the FDA 510(k) submission, it's implied that the data is intended to be representative and valid for the US market. The studies are described as retrospective as they involve samples prepared at specific concentrations or existing clinical samples compared to a gold standard.

3. Number of Experts and their Qualifications

• For Precision/Reproducibility, Cross-Reactivity, Interference, and Method Comparison: The document does not explicitly state the number of "experts" used to establish ground truth or interpret results. These are quantitative/analytical laboratory tests where the ground truth (concentration by LC/MS or GC/MS) is established by analytical instrumentation. The "Viewers" (A, B, C) mentioned in the Method Comparison section appear to be individuals performing the visual interpretation of the device results, not necessarily independent experts establishing ground truth. Their qualifications are not specified but are implied to be trained laboratory personnel.
• For Lay-User Study: No "experts" were used to establish ground truth for the lay-user study. The ground truth for the samples used in this study was established by LC-MS/MS confirming the spiked drug concentrations.

4. Adjudication Method for the Test Set

• For Precision/Reproducibility, Cross-Reactivity, Interference: No adjudication method is described. The results are reported as counts of positive/negative readings against a known (spiked) concentration.
• For Method Comparison: No explicit "adjudication" among multiple readers is described. Results for the candidate device were observed by "Viewer A, B, C." The comparison is directly between the "Candidate Device Result" (presumably individual Viewer results, though aggregated in Table 5) and the LC/MS reference method. The discordant results in Table 6 specify which viewers made the discordant call (e.g., "Viewer A, B," "Viewer C"). This suggests independent readings by three viewers, but no formal adjudication process to resolve disagreements among them is mentioned; the individual viewer calls are presented relative to the ground truth.
• For Lay-User Study: No adjudication method is mentioned. The tables report the number of positive/negative results per concentration.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The study design is an analytical performance study and a comparison study against a laboratory reference method, along with a lay-user study for OTC claims. It assesses device performance in a standalone or simulated user setting, not direct human reader improvement with AI assistance. The device is a lateral flow immunoassay, not an AI-powered diagnostic.

6. Standalone (Algorithm Only) Performance

• This question is not applicable as the device is a lateral flow immunochromatographic assay, not an algorithm or software-based diagnostic. Its performance is inherent to the chemical reactions on the test strip and visual interpretation, not an algorithm.

7. Type of Ground Truth Used

• The primary ground truth used for performance evaluation (Precision/Reproducibility, Method Comparison, Lay-User Study) is analytical confirmation by Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions (LC-MS/MS), which are stated as the "preferred confirmatory methods." This is a highly accurate and quantitative method for determining drug concentrations.

8. Sample Size for the Training Set

• This question is not applicable. The device is a qualitative diagnostic test based on immunoassay principles, not a machine learning or AI-based device that requires a "training set" in the computational sense. The development of the immunoassay itself relies on antigen-antibody binding characteristics and optimization, not a deep learning model.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable for the same reasons as #8. The "ground truth" for developing the test and optimizing its performance would be established through standard immunoassay R&D processes, involving controlled experiments with known concentrations of analytes and cross-reactants, guided by established analytical chemistry principles.

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AllTest Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Urine Test Panel can be a single drug test panel or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinquish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Urine Test Panel and AllTest Multi-Drug Rapid Urine Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a panel format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

The provided document describes the acceptance criteria and study that proves the device (AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel) meets the acceptance criteria.

Note: This device is a qualitative in-vitro diagnostic test, not an AI-based medical device. Therefore, questions related to AI-specific aspects (e.g., number of experts for ground truth, MRMC study, training set, effect size of AI assistance) are not applicable to this submission. The "study" described focuses on analytical performance, method comparison (against a gold standard chemical method), and a lay-person usability study.

1. A table of acceptance criteria and the reported device performance

The document defines performance in terms of precision (reproducibility) and method comparison with LC-MS/MS. The acceptance criteria for these qualitative tests are implicitly demonstrated by the reported agreement with LC-MS/MS results, particularly around the cutoff concentrations. For precision, the goal is consistent detection above the cutoff and consistent non-detection below the cutoff. For method comparison, the aim is high agreement with the confirmatory method, especially for samples near the cutoff.

Table of Performance (Based on "Precision/Reproducibility" and "Method Comparison Study" sections):

• Operator A: 1 sample (494.481 ng/mL, expected positive) was reported positive.
• Operator B: 1 sample (491.559 ng/mL, expected positive) was reported positive, 1 sample (619.861 ng/mL, expected negative) was reported negative.
• Operator C: 1 sample (491.559 ng/mL, expected positive) was reported positive, 1 sample (619.861 ng/mL, expected negative) was reported negative. (The document states "Accurate result" as + or - based on whether it tested above or below the cutoff, implying the device's output. The discordance is when the device's output ("accurate result") doesn't match the LC-MS/MS interpretation.) |
  | BAR | 300 | At Cutoff (300 ng/mL): 21-23 negative / 27-29 positive results out of 50 tests across 3 lots.
  At +25% Cutoff (375 ng/mL): 0-1 negative / 49-50 positive results.
  At -25% Cutoff (225 ng/mL): 50 negative / 0 positive results. | Overall: Good agreement.
  Examples:
• Operator A: 1 sample (304.564 ng/mL, expected negative) was reported negative.
• Operator B: 1 sample (294.112 ng/mL, expected positive) was reported positive.
• Operator C: 1 sample (271.093 ng/mL, expected positive) was reported positive, 1 sample (304.564 ng/mL, expected negative) was reported negative. |
  | BUP | 10 | At Cutoff (10 ng/mL): 24-25 negative / 25-26 positive results out of 50 tests across 3 lots.
  At +25% Cutoff (12.5 ng/mL): 0-1 negative / 49-50 positive results.
  At -25% Cutoff (7.5 ng/mL): 49-50 negative / 0-1 positive results. | Overall: Good agreement.
  Examples:
• Operator A: 1 sample (11.971 ng/mL, expected negative) was reported negative, 1 sample (9.635 ng/mL, expected positive) was reported positive.
• Operator B: 1 sample (10.385 ng/mL, expected negative) was reported negative.
• Operator C: 1 sample (9.149 ng/mL, expected positive) was reported positive. |
  | ... | ... | (Similar patterns observed for all other drugs listed: BZO, COC, MDMA, MET, MOP/OPI, MTD, OXY, PCP, TCA, THC, FYL) | (Similar patterns observed for all other drugs listed, with specific discordant samples detailed in the raw tables. The "Accurate Result" column appears to denote the manual interpretation of the device's result, implying it was designed to align with LC/MS/MS around the cutoff. The discordance is where the device's result does not align with the LC-MS/MS value relative to the cutoff.) |

Key Acceptance Criteria (Implicit from Study Design):

• Precision/Reproducibility: The device should consistently return positive results for samples significantly above the cutoff concentration and consistently negative results for samples significantly below the cutoff. Near the cutoff, a mix of positive and negative results is expected due to inherent assay variability.
• Analytical Specificity/Interference: The device should accurately detect the target drug without significant cross-reactivity from other structurally similar compounds or interference from common endogenous/exogenous substances.
• Method Comparison: A high level of agreement between the device's qualitative results and the quantitative LC-MS/MS confirmatory method, especially for samples near the cutoff.
• Lay Person Usability: Intended lay users should be able to understand and follow instructions and obtain correct results.

2. Sample sizes used for the test set and the data provenance

• Analytical Performance (Precision/Reproducibility):

  • Sample Size: For each drug, 8 concentrations (+100%, +75%, +50%, +25%, cutoff, -25%, -50%, -75%, -100% cutoff). Each concentration was tested two runs per day for 25 days using three lots of test panels.
    • This means (8 concentrations * 2 runs/day * 25 days * 3 lots) = 1200 tests per drug.
  • Data Provenance: Samples were prepared by spiking target drugs into drug-free urine samples. The concentrations were confirmed by LC-MS/MS. This suggests controlled laboratory conditions. The country of origin is not specified but the submitter is Hangzhou AllTest Biotech Co.,Ltd (China) and contact person is in Maryland (USA), so the testing location could be either. Retrospective, as samples were prepared.

• Method Comparison Study:

  • Sample Size: For each drug, 80 unaltered urine clinical samples (40 negative and 40 positive).
  • Data Provenance: "Unaltered urine clinical samples." The source of these clinical samples (e.g., country of origin, prospective or retrospective collection) is not explicitly stated, but "clinical samples" generally implies collection from human subjects. As they were "unaltered," they were likely retrospective, though collection parameters are not detailed.

• Lay Person Study:

  • Sample Size: 140 lay persons.
  • Sample Types: Urine samples created by spiking drug(s) into drug-free pooled urine specimens at various concentrations (-100%, +/-75%, +/-50%, +/-25% of the cutoff). Each participant tested 1 blind-labeled sample. This means 20 samples were used for each of the 7 concentrations (+/-100%, +/-75%, +/-50%, +/-25% of the cutoff for each drug).
  • Data Provenance: Controlled laboratory setting using spiked, blind-labeled samples. The study was performed at "three intended user sites," implying locations where lay persons would typically use such a device. Country not specified. Retrospective setup using prepared samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This device is not an AI-based medical device. Ground truth for the analytical and method comparison studies was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry), which is considered the gold standard for quantitative drug concentration measurement in urine. LC-MS/MS does not rely on expert readers for interpretation in the same way imaging or pathology might.
• For the lay person study, the ground truth was the known concentration of the spiked samples.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Analytical Study (Precision) & Method Comparison: The ground truth was established by LC-MS/MS. The device's result was then compared to this LC-MS/MS reference. There was no "adjudication" in the sense of multiple human readers resolving discrepancies; the LC-MS/MS result served as the definitive reference.
• Lay Person Study: The ground truth was the known concentration of the spiked samples. The lay person's result was compared directly to this known concentration.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool. Its performance is evaluated as a standalone test, and for lay-user interpretation against a ground truth.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, the "Precision/Reproducibility" and "Method Comparison Study" sections represent the standalone performance of the device (which is an immunochromatographic assay, not an algorithm) without human interpretation variability, as results were compared directly to LC-MS/MS.
• The "Lay Person Study" then evaluated human-in-the-loop performance (i.e., how lay users interpret the device's results).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The primary ground truth for the analytical and method comparison studies was LC-MS/MS quantitative analysis, which is a highly accurate chemical method for measuring drug concentrations.
• For the lay person study, the ground truth was the known, spiked concentrations of the drug in the urine samples.

8. The sample size for the training set

• This document describes a 510(k) premarket notification for an in-vitro diagnostic device, not an AI/ML device. Therefore, there is no "training set" in the context of machine learning model development.

9. How the ground truth for the training set was established

• As stated above, this is not an AI/ML device, so there is no "training set." The performance studies rely on LC-MS/MS as the reference method and known spiked concentrations for establishing ground truth for evaluation.

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PocguideTM Multi-Drug Test Cup OTC is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Drug (Identifier) Amphetamine (AMP) Buprenorphine (BUP) Secobarbital (BAR) Oxazepam (BZO) Benzoylecgonine (COC) 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) Methamphetamine (MET) Methylenedioxymethamphetamine (MDMA) Morphine (OPI2000/MOP300) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP) Nortriptyline (TCA) Marijuana (THC)
Cut-off level 1000 ng/mL or 500 ng/mL 10 ng/mL 300 ng/mL 300 ng/mL 300 ng/mL or 150 ng/mL 300 ng/mL 1000 ng/mL or 500 ng/mL 500 ng/mL 2000 ng/mL or 300 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL 1000 ng/mL 50 ng/mL

The single or multi-test cups can consist of up to the above listed analytes in any combination. For over-the-counter use.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

PocguideTM Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

The single or multi-test cups can consist of up to the above listed analytes in any combination.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Pocguide™ Multi-Drug Test Cup OTC and Pocguide™ Multi-Drug Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

The document describes the analytical and user performance of the Pocguide™ Multi-Drug Test Cup OTC and Pocguide™ Multi-Drug Test Cup, which are qualitative lateral flow immunochromatographic assays for detecting various drugs in human urine.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the analytical performance (e.g., specific percentages for precision or method comparison). Instead, it presents the results of these studies. For the lay user study, it presents agreement percentages.

However, based on the data presented, the implicit acceptance criteria for the qualitative detection of drugs would be high agreement (ideally 100% at concentrations sufficiently above or below the cutoff) for positive and negative samples, and a certain degree of variability (discordance) near the cutoff, which is expected for qualitative assays.

Here's a summary of the reported performance, primarily from the "Precision/Reproducibility" and "Method Comparison" sections:

Implicit Acceptance Criteria (based on typical assay performance and the provided data)

• Precision/Reproducibility: Consistent qualitative results (Positive/Negative) across multiple runs and lots, especially for concentrations sufficiently above or below the stated cutoff levels. Some variability (mix of positive and negative results) is expected and acceptable around the cutoff concentration, as this is the region where the device is designed to transition between positive and negative readings.
• Method Comparison (Accuracy vs. LC-MS/MS):
  • 100% agreement for Drug-Free samples (true negatives).
  • High agreement for "Low Negative" samples (true negatives well below cutoff).
  • High agreement for "High Positive" samples (true positives well above cutoff).
  • Expected discordance (mix of +/- results) for "Near Cutoff Negative" and "Near Cutoff Positive" samples.
• Lay Person Study: High percentage of agreement on results, demonstrating ease of use and accurate interpretation by lay users. High Flesch-Kincaid reading score/grade level for instructions indicating understandability.

Reported Device Performance

Precision/Reproducibility (See Tables in Section 12.A.a, e.g., Page 8)

• For concentrations at +100%, +75%, +50%, +25% cutoff: Across all drugs and lots, the device consistently reported 0 negative results and 50 positive results (0-/50+) which indicates 100% agreement for samples well above the cutoff.
• For concentrations at -25%, -50%, -75%, -100% cutoff: Across all drugs and lots, the device consistently reported 50 negative results and 0 positive results (50-/0+) which indicates 100% agreement for samples well below the cutoff.
• For the "Cutoff" concentration: As expected for a qualitative test, there was a mix of negative and positive results across all drugs and lots, ranging from 8-/42+ to 17-/33+ (e.g., for AMP 500 Lot 1, 12-/38+ means 12 negative and 38 positive results out of 50 total). This demonstrates appropriate performance around the threshold.

Method Comparison (Accuracy vs. LC-MS/MS) (See Tables in Section 12.B, e.g., Page 19-20)

• Drug-Free Samples: For all drugs and all three operators, the device consistently reported 0 positive results and showed 100% agreement (e.g., 0+ / 13- for AMP 500).
• Low Negative Samples (less than -50% of cutoff): For all drugs and all operators, the device consistently reported 0 positive results and showed 100% agreement (e.g., 0+ / 7- for AMP 500).
• High Positive Samples (greater than +50% of cutoff): For all drugs and all operators, the device consistently reported 100% positive results (e.g., 23+ / 0- for AMP 500).
• Near Cutoff Negative (Between -50% and cutoff) & Near Cutoff Positive (Between cutoff and +50%): As expected for a qualitative assay, there was a mix of positive and negative results in these ranges, indicating the test's activity around the cutoff. The discordant results table (Pages 22-23) provides specific examples of samples that differ from the LC-MS/MS result near the cutoff. For instance, for AMP 500, samples like AL243 (441.6 ng/mL) were read as Positive by the device, while AL036 (501.2 ng/mL) was read as Negative. This is typical for qualitative tests at the cutoff.

Lay Person Study (See Tables in Section 12.C, e.g., Page 25-27)

• Agreement Percentages: For concentrations well below (-100%, -75%, -50% cutoff) and well above (+50%, +75% cutoff) the cutoff, the agreement with the expected result was consistently 100% for all drugs and configurations.
• Near Cutoff: At the -25% and +25% cutoff concentrations, there was slight variability, with agreement mostly at 95.00% (e.g., 19 negative out of 20 at -25% for AMP 500, or 19 positive out of 20 at +25% for AMP 500). This confirms appropriate performance around the cutoff by lay users.
• Instruction Clarity: "All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7," indicating strong performance against this unstated criterion.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Precision/Reproducibility:
  • Sample Size: For each drug, 9 concentration levels were tested (from -100% cutoff to +100% cutoff, including the cutoff). For each concentration, tests were performed two runs per day for 25 days using three lots of test cups. This means 50 tests per concentration per lot, totaling 450 tests per drug per lot for analytical precision. As there are multiple drugs/cutoffs, the total number of individual tests is substantial. (e.g., for AMP 500, 9 concentrations * 50 tests/concentration * 3 lots = 1350 individual tests for AMP 500 alone).
  • Data Provenance: The document doesn't explicitly state the country of origin. Samples were "prepared by spiking target drug in drug-free urine samples," suggesting controlled laboratory conditions rather than native clinical samples. The study appears to be prospective in nature, as it involves preparing samples and running specific experiments.
• Method Comparison Study:
  • Sample Size: 80 "unaltered urine clinical samples" were used for each drug (40 negative and 40 positive). These were compared across three operators. Thus, for each drug, 80 unique clinical samples were tested, with data collected from 3 operators, meaning 240 results per drug.
  • Data Provenance: "Unaltered urine clinical samples" suggests real-world urine specimens. The document doesn't specify the country of origin of these samples. It implies a retrospective use of collected samples or a prospective collection for this specific study.
• Lay Person Study:
  • Sample Size: 280 lay persons participated. Urine samples were prepared at 7 concentration levels per drug (from -100% to +75% cutoff).
  • Data Provenance: The study was likely conducted in a controlled environment as samples were "prepared by spiking drug(s) into drug free-pooled urine specimens." The location (country) of the lay user study is not specified, but it suggests a controlled, prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Ground Truth for Precision/Reproducibility and Lay Person Study: "Each drug concentration was confirmed by LC-MS/MS." and "The concentrations of the samples were confirmed by LC-MS/MS." LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is a highly accurate analytical chemistry technique. This is an objective, quantitative measurement; therefore, human expert subjective interpretation for ground truth establishment is not typically required.
• Ground Truth for Method Comparison Study: "The samples were blind labeled and compared to LC-MS/MS results." Again, LC-MS/MS is the ground truth, not human experts.

As such, for an in-vitro diagnostic device of this nature, the "ground truth" is established by highly precise analytical instruments (LC-MS/MS), not by human experts. Therefore, the number and qualifications of human experts establishing ground truth are not applicable in the traditional sense of medical image interpretation or clinical diagnosis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The ground truth method (LC-MS/MS) for defining the precise concentration of drugs is an objective chemical analysis, not a subjective human interpretation requiring adjudication. For the device's output, it is a qualitative "positive" or "negative" reading based on visual lines, directly observable without complex adjudication. The method comparison study uses results from 3 operators, but their results are compared against the LC-MS/MS, not adjudicated against each other to define a 'truth'.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in-vitro diagnostic (IVD) device, specifically a point-of-care, qualitative multi-drug test cup, not an AI-assisted diagnostic tool for human image readers (like radiology AI). Therefore, an MRMC study related to AI assistance for human readers is not relevant to this product.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical, self-contained immunochromatographic test cup that provides a visual reading (lines appearing/disappearing). It does not involve a software algorithm that performs detection independently. Its performance is the "standalone" performance, as it relies on chemical reactions and visual interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used for performance evaluation is Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions (LC-MS/MS), which are considered the preferred confirmatory methods for drug detection in urine. This is an objective, quantitative chemical analysis.

8. The sample size for the training set

Not applicable. This is a direct chemical/immunological assay device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data-driven model development.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of medical device. The device operates based on established chemical and immunological principles, not learning from data.

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AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these crugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.

The document describes the "AllTest Multi-Drug Urine Test Cup" and "AllTest Multi-Drug Rapid Urine Test Cup" and their performance characteristics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically demonstrated through precision studies, where the device consistently identifies samples at, above, and below predefined cutoff concentrations. The performance data presented in the "Precision/Reproducibility" section serves as the primary evidence. For qualitative tests, the acceptance criteria relate to the agreement with expected results at various concentrations relative to the cutoff.

Acceptance Criteria (Implied from the study design):

• At or above +25% cutoff: Expected to report as "Positive" (drug detected).
• At or below -25% cutoff: Expected to report as "Negative" (no drug detected).
• Around cutoff (+/- 25% of cutoff): A mix of positive and negative results is expected, reflecting the inherent variability near the cutoff threshold. This range is often considered the "equivocal" zone.
• Specificity (Cross-Reactivity): Low cross-reactivity with non-target compounds.
• Interference: No significant interference from common urine interferents or variations in pH and specific gravity.
• Lay-person usability: High agreement rate for lay users.

Reported Device Performance (from "Precision/Reproducibility" and "Lay Person Study"):

2. Sample Size and Data Provenance for Test Set

• Precision/Reproducibility Study:

  • Sample Size: For each drug concentration level (e.g., +100% cutoff, -100% cutoff, and 7 intermediate levels), tests were performed two runs per day for 25 days using three lots of test cups. This means for each drug and each concentration, there were 2 runs/day * 25 days/lot * 3 lots = 150 test results recorded (number of negative and positive results).
  • Data Provenance: Samples were prepared by spiking target drugs into drug-free urine samples. The origin of the "drug-free urine samples" is not explicitly stated (e.g., country of origin). The study is retrospective in the sense that samples were artificially prepared and spiked, but prospective in the sense of testing these prepared samples by the device.

• Method Comparison Study:

  • Sample Size: 80 unaltered urine clinical samples were used for each drug (40 negative and 40 positive). This means 80 clinical samples per drug were tested against LC-MS/MS.
  • Data Provenance: "unaltered urine clinical samples" - the country of origin is not specified. The study is retrospective as pre-collected samples were tested.

• Lay Person Study:

  • Sample Size: 140 lay persons. 20 samples were tested per concentration level for each drug. The samples were prepared by spiking drug(s) into drug-free pooled urine specimens at various concentrations.
  • Data Provenance: Not specified for the drug-free pooled urine or the participants' origin. This study is prospective for the participants interacting with the device, but the samples themselves were artificially prepared.

3. Number of Experts and Qualifications for Ground Truth - Test Set

• Precision/Reproducibility Study: The ground truth was established by the manufacturer. "Each drug concentration was confirmed by LC-MS/MS." LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is a highly accurate analytical chemistry technique. The individuals performing or analyzing LC-MS/MS results are typically trained laboratory technicians or chemists, but their specific "expert" qualifications (e.g., years of experience, certification) are not detailed.
• Method Comparison Study: The ground truth was established using LC-MS/MS results. Similar to the precision study, this relies on a precise analytical method, implying expert knowledge in operating and interpreting LC-MS/MS, but specific qualifications of individuals are not provided.
• Lay Person Study: The ground truth for the spiked samples was confirmed by LC-MS/MS.

4. Adjudication Method for Test Set

• Precision/Reproducibility Study: Not applicable in the traditional sense, as the ground truth was analytically determined by LC-MS/MS concentrations. The results are presented as counts of positive/negative.
• Method Comparison Study: Not applicable. The device's results were directly compared to the LC-MS/MS results. Discordant results (where the device disagreed with LC-MS/MS) are listed individually, but no further adjudication process is described beyond the quantitative LC-MS/MS result being the "Accurate Result."
• Lay Person Study: Not applicable. Lay users interpreted the device, and their interpretations were compared to the LC-MS/MS confirmed concentrations of the spiked samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a rapid diagnostic test cup, not an AI-powered diagnostic system requiring human interpretation comparison. The "Lay person study" involved human readers (lay persons) but it was to assess their ability to use and interpret the device alone, not in comparison to an assisted workflow.

6. Standalone Performance

Yes, a standalone performance study was done. The precision/reproducibility and method comparison studies directly assess the algorithm's (the device's) performance in detecting drugs in urine samples compared to established analytical methods (LC-MS/MS) without human-in-the-loop assistance influencing the result (though humans perform the test and read the result line on the cup). The "Lay person study" also shows standalone performance as interpreted by lay users.

7. Type of Ground Truth Used

• Analytical Ground Truth: For the "Precision/Reproducibility" and "Lay Person" studies, the ground truth was analytically determined concentrations confirmed by LC-MS/MS after spiking known amounts of drugs into drug-free urine.
• Confirmatory Method Ground Truth: For the "Method Comparison Study," the ground truth was established by LC-MS/MS results on unaltered urine clinical samples.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI model development. This device is a rapid immunochromatographic assay, which is a chemical and biological test, not typically an AI/machine learning device that requires a training set. The various studies (precision, method comparison, lay person) serve as validation of the device's performance.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned for an AI/ML algorithm, this question is not applicable. The device itself is based on antigen-antibody reactions, not a trained algorithm.

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